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Stroke Device Cleared for Larger Catheters

[ Price : $8.95]

FDA clears an Imperative Care 510(k) for its Zoom System, a stroke thrombectomy system with .088-inch catheters.

Supernus Wins Label Update for ADHD Drug

[ Price : $8.95]

FDA approves a Supernus Pharmaceuticals label update for attention-deficit/hyperactivity disorder drug Qelbree (viloxazine extende...

Provepharm Recalls Phenylephrine HCl

[ Price : $8.95]

Provepharm recalls one lot of phenylephrine hydrochloride injection, USP, 10 mg/mL due to a customer complaint about visible black...

Once Monthly Leqembi for Alzheimers Approved

[ Price : $8.95]

FDA approves an Eisai/Biogen supplemental BLA for Leqembi (lecanemab-irmb) and its intravenous use once every four weeks as mainte...

Pfizer Pays $60 million to Settle Biohaven Kickbacks

[ Price : $8.95]

Pfizer agrees to pay $59.7 million to resolve allegations that its subsidiary, Biohaven Pharmaceutical, engaged in previous illega...

Vanda Files NDA for Motion Sickness Drug

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Vanda Pharmaceuticals files an NDA for tradipitant for treating motion sickness.

ALX Oncology Seeking Accelerated OK for Evorpacept

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ALX Oncology plans to discuss with FDA its path for seeking accelerated approval for CD47-blocker evorpacept based on positive upd...

FDA Approves Medexus Leukemia NDA

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FDA approves a Medexus NDA for Grafapex (treosulfan) for use with fludarabine as a preparative regimen for allogeneic hematopoiet...

FDA Delays Non-Rx Drug Final Rule

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Responding to a Trump Administration order, FDA delays the effective date until 3/21 of a recent final rule entitled Nonprescripti...

CDRHs Sara Brenner Elevated to Acting Commissioner

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HHS elevates CDRH chief medical officer for in vitro diagnostics Sara Brenner to FDA acting commissioner under the Trump Administr...